{"id":1072,"date":"2017-11-08T11:59:32","date_gmt":"2017-11-08T11:59:32","guid":{"rendered":"https:\/\/www.groupactionlawyers.co.uk\/blog\/?p=1072"},"modified":"2017-11-08T11:59:32","modified_gmt":"2017-11-08T11:59:32","slug":"medical-device-alert-datascope-corp-intra-aortic-balloon-pumps","status":"publish","type":"post","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/medical-device-alert-datascope-corp-intra-aortic-balloon-pumps","title":{"rendered":"Medical device alert for Datascope Corp intra-aortic balloon pumps"},"content":{"rendered":"

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for intra-aortic balloon pumps manufactured by Datascope Corp.<\/p>\n

Models CS100, CS100i and CS300 are reportedly at risk of “haemodynamic instability to patients with critical care conditions due to a delay in, or sudden interruption of, therapy.”<\/p>\n

The medical device cites at least one report of a death involving an allegedly failed CS300 intra-aortic balloon pump. It’s not known how many non-fatal injuries have been caused by the faulty pumps as well.
\n<\/p>\n

About the issue<\/h2>\n

The balloon is hooked up to a machine that pumps it up in time with the heart to assist with blood flow. The electronic inflation and deflation of the balloon creates a vacuum, forcing the blood to be pumped out of the heart and into the arteries. It increases the amount of oxygen infused into the blood cells, ready to be carried to the rest of the body. <\/p>\n

However, the electrical fault to the solenoid valve can mean the device might not start<\/strong>, or the balloon could stop inflating and deflating<\/strong>. When this happens, the patient may be at risk of not receiving enough blood and oxygen to other parts of their body, or they may even form a deadly blood clot.<\/p>\n

Action being taken<\/h3>\n

Manufacturers are working on replacing the faulty driver boards for the solenoid boards, but in the meantime physicians are urged to seek alternative devices or therapy. <\/p>\n

For those who don’t have an alternative method of treatment, physicians are being asked to carefully analyse the risks and benefits of using the affected devices. They will also need to notify patients<\/strong> of the alerted risk in using the affected devices, and failure to do so could mean that any patient who suffers because they weren’t duly informed about the risks may have a legal case<\/strong>.<\/p>\n

Physicians who choose to use an affected device must not leave the patient unattended. <\/p>\n

If the balloon stops working for more than half an hour, the patient is at risk of developing a blood clot that could easily be fatal. <\/p>\n

The risk of haemodynamic instability is just as dangerous as abnormal or unsteady blood flow that can lead to internal organs not getting enough oxygen and failing to work.<\/p>\n","protected":false},"excerpt":{"rendered":"

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for intra-aortic balloon pumps manufactured by Datascope Corp. Models CS100, CS100i and CS300 are reportedly at risk of “haemodynamic instability to patients with critical care conditions due to a delay in, or sudden interruption of, therapy.” The medical device cites at … Continue reading Medical device alert for Datascope Corp intra-aortic balloon pumps<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":389,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[5],"tags":[20],"class_list":["post-1072","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-mhra"],"yoast_head":"\nMedical Device Alert For Datascope Corp Intra-Aortic Balloon Pumps<\/title>\n<meta name=\"description\" content=\"A 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The CARDIOSAVE hybrid intra-aortic balloon pump (IABP) and CARDIOSAVE rescue IABP have been reported to have damaged lithium-ion batteries that may give off smoke, a bad smell, or\u2026","rel":"","context":"In "Medical"","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":627,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/carefusion-syringe-pumps-incompatible-with-any-syringe-type","url_meta":{"origin":1072,"position":2},"title":"CareFusion syringe pumps are incompatible with any syringe type","author":"Admin","date":"27th April 2017","format":false,"excerpt":"Following on from medical device alerts from the Medicines and Healthcare products Regulatory Agency (MHRA), CareFusion has made updates and replacements to the MDA\/2016\/023 Alaris syringe pumps that were at risk of having uncontrolled bolus i.e. chewed up amounts of substances from the medicine. Medical device alert 1 On 22nd\u2026","rel":"","context":"In "Medical"","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/medical.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":1081,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/mechanical-heart-valves-alert-over-risk-inverted-implantation","url_meta":{"origin":1072,"position":3},"title":"Medical device alert issued over bi-leaflet mechanical heart valves over risk of inverted implantation","author":"Admin","date":"13th November 2017","format":false,"excerpt":"Over the past 15 years, the Medicines and Healthcare product Regulation Agency (MHRA) has been made aware of five incidents where a mechanical bi-leaflet prosthetic valve has been implanted the wrong way round because they were put in the holders upside down. The MHRA is afraid that, due to under-reporting,\u2026","rel":"","context":"In "Medical"","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical device alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2017\/04\/medical-device-alert.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":428,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/alaris-syringe-pumps-health-risk-when-using-non-recommended-syringes","url_meta":{"origin":1072,"position":4},"title":"Using non-recommended syringe with Alaris syringe pumps could be a health risk","author":"Author","date":"31st December 2016","format":false,"excerpt":"There is a reported risk with the use of non-recommended syringes in Alaris syringe pumps, manufactured by CareFusion. The non-recommended syringes are reported to have a broken spring in the plunger which may cause unintended bolus (usually chewed up mass in the mouth) of medication. MHRA medical alert The problem\u2026","rel":"","context":"In "Medical"","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/12\/healthcare-apps.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]},{"id":767,"url":"https:\/\/www.groupactionlawyers.co.uk\/blog\/accu-chek-insight-insulin-pumps-battery-life-issues","url_meta":{"origin":1072,"position":5},"title":"Issues with battery life of the Accu-Chek Insight insulin pumps","author":"Admin","date":"26th June 2017","format":false,"excerpt":"All Accu-Chek Insight insulin pumps have received new instructions for better device management due to previous complaints about the battery lifetime and the device having unexpected shutdowns. The first warning for the medical device was issued on the 4th August 2015 where Roche Diabetes Care, the medical manufacturers of the\u2026","rel":"","context":"In "Medical"","block_context":{"text":"Medical","link":"https:\/\/www.groupactionlawyers.co.uk\/blog\/category\/medical"},"img":{"alt_text":"medical alert","src":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=350%2C200 1x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=525%2C300 1.5x, https:\/\/i0.wp.com\/www.groupactionlawyers.co.uk\/blog\/wp-content\/uploads\/2016\/08\/medical_alert.png?fit=725%2C250&ssl=1&resize=700%2C400 2x"},"classes":[]}],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1072","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/comments?post=1072"}],"version-history":[{"count":2,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1072\/revisions"}],"predecessor-version":[{"id":1077,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/posts\/1072\/revisions\/1077"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media\/389"}],"wp:attachment":[{"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/media?parent=1072"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/categories?post=1072"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.groupactionlawyers.co.uk\/blog\/wp-json\/wp\/v2\/tags?post=1072"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}